Revelation Biosciences Inc. Announces First Group of

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SAN DIEGO, Jan. 20, 2022 (GLOBE NEWSWIRE) — Revelation Biosciences Inc. (NASDAQ: REVB) (the “Company” or “Revelation”), a clinical-stage life sciences company focused on developing therapies based on disease prevention and treatment, today announced that the first group of 15 patients have been enrolled and dosed in a Phase 2b viral challenge study (RVL-VRL01) to assess the efficacy of REVTx -99 intranasal for the prophylaxis of H3N2 influenza (influenza A) infection in healthy humans. The study is being conducted in Belgium and is recruiting healthy people between the ages of 18 and 55.

REVTx-99 activates a non-specific (innate) immune response which differentiates it from most current treatments that focus on a specific (adaptive) immune response potentially allowing wider use in most infectious viruses. The viral challenge study is the next necessary step in the clinical development of REVTx-99 for the treatment of viral respiratory infections. Future development plans include clinical studies on SARS-CoV-2 and its variants, as well as other respiratory viruses.

“With viral respiratory infections like influenza, COVID-19 and its emerging variants, there is a huge need for new therapies, said James Rolke, chief executive of Revelation. “The results of this study will be an important step in the development of REVTx-99. Despite the presence of vaccines, there remains an urgent need for multiple therapeutic approaches to help prevent and treat respiratory viral infections.

The Phase 2b, randomized, double-blind, placebo-controlled study will enroll up to 60 participants (four groups of 15 patients). The primary endpoint is to assess the efficacy of REVTx-99 in reducing influenza viral load from the area under the curve (AUC) in the upper respiratory tract during infection. Key secondary endpoints include: AUC of total symptom score, duration of symptoms, peak symptom score, peak viral load, duration of influenza virus presence, incidence of mild to moderate influenza (MMID) and the incidence of seroconversion.

The study will have multiple and single dose randomized cohorts. The effectiveness of interventional strategies should be assessed by measuring the incidence and severity of disease in the active treatment groups versus the placebo group, as well as safety parameters associated with adverse events and airway physiology.

Revelation expects major data in the second quarter of 2022.

For more information about Revelation, please visit www.RevBiosciences.com.

About REVTx-99

REVTx-99 is a proprietary intranasal drop formulation under development for the prevention or treatment of viral respiratory infections and is broadly applicable to most infectious viruses including influenza A, influenza B, parainfluenza, rhinovirus , respiratory syncytial virus (RSV), SARS-CoV-2, and its variants. The active ingredient in REVTx-99 stimulates the innate nasal (mucosal) immune system via interaction with the toll-like receptor 4 (TLR4) to produce protective cytokines, including interferons and interferon-related proteins. These protective cytokines work in concert to dampen an invading virus’s ability to proliferate and survive. Phase 1 data showed that REVTx-99 was well tolerated and significantly increased intranasal protective cytokines. Additionally, REVTx-99 was evaluated for in vitro prophylactic antiviral activity against SARS-CoV-2 Delta infection in three distinct cell lines, each expressing sufficient levels of ACEII and TLR4, receptors necessary for sufficiently demonstrate viral infection as well as REVTx-99 activity, respectively. In these in vitro studies, REVTx-99 caused a significant decrease in viral load with prophylactic treatment.

In addition to viral infection, REVTx-99 is also being developed for the management of symptoms of allergic rhinitis and chronic nasal congestion without polyps. REVTx-99 upregulates a protein that competes for the native eotaxin receptor, CCR3, preventing eotaxin from recruiting eosinophils, thereby reducing Th2 cell recruitment and attenuating the allergic response.

About Revelation Biosciences Inc.

Revelation Biosciences, Inc. is a clinical-stage life sciences company focused on the development of immunological therapies for the prevention and treatment of disease. Revelation has several product candidates in development. REVTx-99, the lead therapeutic candidate, is an intranasal immunomodulator to prevent or treat infections caused by various respiratory viruses such as SARS-CoV-2, including its variants, influenza A and B, parainfluenza, rhinovirus and the RSV. REVTx-99 is also under development for other indications such as: allergic rhinitis and chronic nasal congestion. REVTx-200 is an intranasal immunomodulatory supplement to be used in combination with intramuscular vaccination for more complete immunity. REVTx-200 is based on the same technology used in REVTx-99. In addition to Revelation’s therapeutic pipeline, Revelation is also developing REVDx-501, a home-use rapid diagnostic that can be used to detect any respiratory viral infection, regardless of virus type or strain, without the need for specialized instruments. .

For more information about Revelation, please visit www.RevBiosciences.com.

Forward-looking statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These forward-looking statements are generally identified by the words “anticipate”, “believe”, “expect”, “estimate”, “plan”, “outlook” and “project” and similar expressions. We caution investors that forward-looking statements are based on management’s expectations and are only predictions or statements of current expectations and involve known and unknown risks, uncertainties and other factors that may cause actual results may differ materially from those anticipated by the forward-looking statements. statements. Revelation cautions readers not to place undue reliance on these forward-looking statements, which speak only as of the date they were made. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: Revelation’s ability to achieve its financial and strategic objectives, due to, among other things, competition; Revelation’s ability to grow and manage the profitability of growth and retain its key employees; the possibility that the Disclosure may be adversely affected by other economic, business and/or competitive factors; risks associated with the successful development of Revelation’s product candidates; the clinical utility of increased intranasal cytokine levels as a biomarker of viral infections; the ability to complete planned clinical studies of REVTx-99; the risks associated with the success of the RVL-CLR01 and RVL-VRL01 clinical studies; the risk that we may not be able to fully enroll our clinical studies or that enrollment may take longer than expected; risks related to the occurrence of adverse safety events and/or unexpected concerns that may arise from data or analyzes from our clinical studies; changes in applicable laws or regulations; planned start of clinical studies, schedule of clinical data; the outcome of the clinical data, including whether the results of this study are positive or whether they can be reproduced; the result of the data collected, including whether the results of such data and/or correlations can be reproduced; the timing, costs, conduct and results of our other clinical studies; anticipated processing of future clinical data by the FDA, EMA or other regulatory authorities, including whether such data will be sufficient for approval; the success of future development activities for REVTx-99 and extended indications, REVTx-200, REVDx-501 or any other product candidates; potential indications for which product candidates may be developed; the potential impact that COVID-19 may have on Revelation’s suppliers, vendors, regulatory agencies, employees and global economy; the ability of Revelation to maintain the listing of its securities on NASDAQ; the expected length of time Revelation balances will fund its operations; and other risks and uncertainties described herein, as well as the risks and uncertainties discussed from time to time in other reports and other public filings with the SEC by Revelation.

Company details

Sandra Vedrick
Vice President, Investor Relations and Human Resources
Revelation Biosciences Inc.
Email: [email protected]

and

Chester Zygmont, III
Financial director
Revelation Biosciences Inc.
Email: [email protected]

Media contact:
Kristin Faulder
[email protected]

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